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HypercholesterolemiaPhase 2NCT05795517

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）

A Phase 2 study testing HSK31679 low dose, HSK31679 medium dose and HSK31679 high dose in people with Hypercholesterolemia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
HSK31679 low dose, HSK31679 medium dose and HSK31679 high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
1 siteChina
Study dates
26 Apr 2023to 1 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be willing to participate in the study and provide written informed consent.
  • Male or female aged 18 ≤ age < 65 at the time of signing the informed consent.
  • At the time of screening, patients who had not received lipid-regulation therapy within 6 weeks had fasting LDL-C≥3.34mmol/L（130mg/dL）.
  • (BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg.
  • During screening, fasting triglyceride (TG) <5.65 mmol/L.
  • During screening,MRI-PDFF≥8%.
  • Weight changes≤5% in the 4 weeks prior to screening.

Who cannot join

  • Did not discontinue any lipid-regulating therapy or any drug or supplement that may affect lipid levels 6 weeks before randomization or is expected to do so during the study period.
  • Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria.
  • Dyslipidemia caused by other diseases or drugs, such as rheumatoid arthritis, nephrotic syndrome, Cushing's syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovarian syndrome, etc
  • Before screening, LDL-C plasma exchange was performed within 12 months.
  • In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment.
  • uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline.
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  • type 1 diabetes, or newly diagnosed type 2 diabetes within 1 month, or poorly controlled type 2 diabetes, or who could not maintain the same hypoglycemic regimen during the study.
  • Stroke or transient ischemic attack (TIA), acute coronary syndrome, stable angina attack, severe deep vein thrombosis, or pulmonary embolism occurred in the 12 months prior to screening.
  • Major surgery (including but not limited to: coronary or other revascularization, coronary artery bypass surgery, and transplantation) within 12 months prior to screening or planned during the study period.
  • Chronic systemic disease or history, including but not limited to
  • Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history
  • Have thyroid disease or symptomatic abnormalities in thyroid function tests (e.g., thyroid stimulating hormone (TSH) < 1.0 x lower limit of normal (LLN) or > 1.5 x upper limit of normal (ULN))
  • History of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening
  • Disease or medical history assessed by the investigator as likely to affect the study
  • Bariatric surgery within 12 months at the time of screening

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tsinghua Changgung Hospital, Tsinghua University

    Beijing

Other trials in China

About this study

Official title: A Phase 2 ,Multicentre, Randomised, Double Blind Double Simulation, Placebo and Positive Controlled Study to Evaluate the Efficacy and Safety of HSK31679 in Patients With Hypercholesterolemia With Non-alcoholic Fatty Liver Disease

The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).

Being tested
HSK31679 low dose, HSK31679 medium dose, HSK31679 high dose, Placebo, Ezetimibe 10mg
Keywords
hypercholesterolemia, non-alcoholic fatty liver disease(NAFLD), THR-β
Medical subject headings
Hypercholesterolemia, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK31679 low doseDrug

    HSK31679 low dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

  • HSK31679 medium doseDrug

    HSK31679 medium dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

  • HSK31679 high doseDrug

    HSK31679 high dose and placebo of HSK31679 ，QD，oral，Day1 to week 12

  • PlaceboDrug

    placebo ，QD，oral，Day1 to week 12

  • Ezetimibe 10mgDrug

    Ezetimibe 10mg+placebo of HSK31679 ，QD，oral，Day1 to week 12

Study groups in NCT05795517
Study groupRoleWhat they receive
HSK31679 low doseExperimentalNot described
Receives: Drug: HSK31679 low dose
HSK31679 medium doseExperimentalNot described
Receives: Drug: HSK31679 medium dose
HSK31679 high doseExperimentalNot described
Receives: Drug: HSK31679 high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
EzetimibeActive comparatorNot described
Receives: Drug: Ezetimibe 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in LDL-C from baseline at 12 week;

    Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 12 weeks of treatment;

    Measured: Baseline and Week 12

  2. Percentage change in MRI-PDFF from baseline at 12 week；

    Percentage change of MRI-PDFF(change in liver fat content by nuclear magnetic resonance - Proton Density Fat Fraction) from baseline after 12 weeks of treatment;

    Measured: Baseline and Week 12

Secondary outcomes (9)

  1. Percentage change in fasting LDL-C from baseline;

    Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 2, 4, and 8 weeks of treatment;

    Measured: Week2,4,8

  2. The proportion of patients with MRI-PDFF decreased by > 30%

    After 12 weeks of treatment, the proportion of patients with MRI-PDFF decreased by > 30%;

    Measured: Baseline and Week 12

  3. Proportion of patients with LDL-C<3.34mmol/L（<130mg/dL）

    After 12 weeks of treatment, the proportion of patients with LDL-C<3.34mmol/L（<130mg/dL）

    Measured: Baseline and Week 12

  4. Percentage change of fasting TG from baseline;

    After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting triglycerides (TG), from baseline;

    Measured: Week2,4,8,12

  5. Percentage change of fasting TC from baseline;

    After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting total cholesterol (TC) from baseline;

    Measured: Week2,4,8,12

  6. Percentage change of fasting HDL-C from baseline;

    After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting high-density lipoprotein cholesterol (HDL-C) from baseline;

    Measured: Week2,4,8,12

  7. Percentage change in body weight from baseline

    Percentage change in body weight from baseline after 12 weeks of treatment.

    Measured: Baseline and Week 12

  8. AUC0-τ of HSK31679 (All subjects)

    Measured: up to 2,4,7 weeks

  9. Cmax of HSK31679 (All subjects)

    Measured: up to 2,4,7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start26 Apr 2023
  3. Primary completion20 Feb 2024
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795517
Sponsor's protocol ID
HSK31679-201
Status last verified
Apr 2024
First submitted
9 Mar 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xue F, Ma W, Gao J, Chen J, Yue W, Bu P, Chen Q, Chen H, Sheng J, Chen L, Liu F, Li G, Zhu C, Zhong B, Zhang J, Cai Q, Wang L, Chen Y, Pei Z, Yao L, Lv L, Gao Y, Xia B, Ji X, Liu Y, Du L, Ma G, Hao K, Li F, Wu T, Huo Y, Wei L. Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Apr;24(4):1068-1078. doi: 10.1016/j.cgh.2025.08.009. Epub 2025 Aug 20.

    PubMed 40846146

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK31679 low dose, HSK31679 medium dose and HSK31679 high dose in people with Hypercholesterolemia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in LDL-C from baseline at 12 week; (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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